Scribd Logo
Upload

Welcome to Scribd!

  • 220 views

    Vendor Qualification For Raw Material and Packaging Materials

    Uploaded by

    049 Nishigandha Nadavade
    This document provides a procedure for identifying, selecting, evaluating, and qualifying vendors of raw materials and packaging materials. It outlines identifying potential vendors, selecting vendors based on their capabilities and qualifications, and evaluating vendors to ensure they meet relevant criteria before materials can be used commercially. Vendors must be requalified periodically, with active raw material vendors requalified every two years and other materials like inactive raw materials and packaging materials requalified every four years. Qualification of alternate vendors can also be initiated through a change request notice.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd

    Vendor Qualification For Raw Material and Packaging Materials

    Uploaded by

    049 Nishigandha Nadavade
    220 views2 pages
    This document provides a procedure for identifying, selecting, evaluating, and qualifying vendors of raw materials and packaging materials. It outlines identifying potential vendors, selecting vendors based on their capabilities and qualifications, and evaluating vendors to ensure they meet relevant criteria before materials can be used commercially. Vendors must be requalified periodically, with active raw material vendors requalified every two years and other materials like inactive raw materials and packaging materials requalified every four years. Qualification of alternate vendors can also be initiated through a change request notice.

    Original Title

    Vendor Qualification for Raw Material and Packaging Materials

    Copyright

    © © All Rights Reserved

    Available Formats

    PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    This document provides a procedure for identifying, selecting, evaluating, and qualifying vendors of raw materials and packaging materials. It outlines identifying potential vendors, selecting vendors based on their capabilities and qualifications, and evaluating vendors to ensure they meet relevant criteria before materials can be used commercially. Vendors must be requalified periodically, with active raw material vendors requalified every two years and other materials like inactive raw materials and packaging materials requalified every four years. Qualification of alternate vendors can also be initiated through a change request notice.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    220 views2 pages

    Vendor Qualification For Raw Material and Packaging Materials

    Uploaded by

    049 Nishigandha Nadavade
    This document provides a procedure for identifying, selecting, evaluating, and qualifying vendors of raw materials and packaging materials. It outlines identifying potential vendors, selecting vendors based on their capabilities and qualifications, and evaluating vendors to ensure they meet relevant criteria before materials can be used commercially. Vendors must be requalified periodically, with active raw material vendors requalified every two years and other materials like inactive raw materials and packaging materials requalified every four years. Qualification of alternate vendors can also be initiated through a change request notice.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    You are on page 1of 2

    Vendor Qualification for Raw Material and Packaging Materials

    Objective-
    To provide procedure for identification, selection, evaluation and qualification of Raw Material
    (Active and Inactive) and Primary / Printed Packaging material vendors

    Procedure-
    Identification of Vendor
    Identify vendor(s) for each raw material and primary/printed packaging material.

    Selection of Vendor
    Selection of Vendor shall be made after evaluating the following factors.
     The Vendor’s capability to supply the required quality of material.
     The Vendor’s capability to supply the required quantity.
     Reputation and reliability of the Vendor.
     Whether Vendor is a DMF holder/inspected by Regulatory agencies/ISO.
     The Vendor’s capability to expand to the increased need, if any.
     Whether the vendor is the manufacturer or distributor.

    Evaluation and Qualification


    Vendor of each material shall meet the following relevant qualification criteria before
    commercialization of drug product using the material.

    Raw materials
     Certification by officially accredited body.
     Self-assessment by the vendor.

    Primary / Printed Packaging Materials


     One lot from the vendor satisfactorily tested and approved as per specifications.
     Certification of the vendor based on any of the following.
     Satisfactory on-site inspection (For specimen checklist refer Annexure-2).
     Certification by officially accredited body.
     Self-assessment by the vendor.

    Requalification of Vendor
     Vendor shall be requalified periodically in the following manner.
     Complete testing of one lot of material at frequency specified in SOP ‘Reduced testing
    procedure’.
     Re-certification through the procedure outlined above

    Active Raw material: Once in two years


    Inactive Raw material: Once in four years
    Primary / printed packaging material: Once in four years

    Qualification of Alternate vendor


    Qualification of alternate vendor shall be initiated through change request notice.
    CRN shall be circulated to R&D, QC, IRA, QA, SCM and other concerned departments.

    You might also like